Bluebird opens manufacturing facility as it moves gene therapies forward

In an indication of where the growth in the pharma industry is developing, Bluebird Bio is the latest to complete a new viral vector manufacturing facility to produce the investigational gene and cell therapies it is working on.

The biotech is in the process of qualifying the 125,000-square-foot lentiviral vector facility in Durham, North Carolina, in which it is investing $80 million. About 50 employees work there now, and the company thinks that number will grow to 70 by the end of 2019.

Bluebird CEO Nick Leschly said the facility “is a crucial step toward our mission of bringing a new generation of treatments to people living with severe genetic diseases and cancer.”

Among others, the biotech is working on two cell and gene therapies of the treatment of multiple myeloma and potentially LentiGlobin, its potential treatment for transfusion-dependent β-thalassemia (TDT) and sickle cell disease. The company announced today that the European Medicines Agency issued an approval for the conditional Marketing Authorization Application for its LentiGlobin.

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This is the first manufacturing facility for the Cambridge, Massachusetts-based biotech and is designed to handle both clinical and commercial supply of lentiviral vector, a key component of gene and cell therapies. It is, however, large enough to expand into commercial production if its candidates get approved, the company said. It includes warehouse and quality control testing laboratories in addition to the multiple manufacturing suites.

In addition to the Durham facility, Bluebird has multiyear manufacturing agreements for the U.S. and Europe with Novasep for its site in Gosselies, Belgium, with Merck KGaA’s MilliporeSigma, for its site in Carlsbad, California and with Brammer Bio for its site in Cambridge, Massachusetts.

Thermo Fisher Scientific on Monday announced a deal to buy Brammer for $1.7 billion and fold it into its pharma services operations. That deal is slated to close by the end of the the second quarter.